Intravenous CathetersNCT03457259
The Clinical Efficacy of Midline Catheters
A study testing PVC and/or PICCline and Midline in people with Intravenous Catheters, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Catheters
- What is being tested?
- PVC and/or PICCline and Midline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Feb 2018to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the Department of Infectious Disease or Department of Heart Disease.
- ≥18 years of age
- Expected requirement for iv. therapy >5 days from the day of enrolment as evaluated by a specialist in infectious diseases.
- Mentally competency
Who cannot join
- Lack of patient consent
- Requirement for a CVC before study eligibility screening or anticipation of an absolute indication for CVC inserted within 24 hours of screening
- Personnel for insertion of midline catheter not available
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesiology and Intensive Care East Section, Aarhus University
Aarhus, 8000
About this study
Official title: The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study
The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.
- Conditions
- Intravenous Catheters
- Being tested
- PVC and/or PICCline, Midline
- Keywords
- Midline catheter, peripheral venous catheter, central venous catheter, complication rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVC and/or PICClineDevice
Also called Conventional catheterization
Pt. will receive PVC and/or PICCline
MidlineDevice
Also called Powerglide
Pt. will receive midline
| Study group | Role | What they receive |
|---|---|---|
| Midline | Active comparator | Pt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound. Receives: Device: Midline |
| Conventional | Active comparator | Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered. Receives: Device: PVC and/or PICCline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the use of CVC and PVC
The fraction of patients requiring either a CVC - including PICC line - or require ≥ 4PVC insertions during the current admittance to the hospital, including follow-up intravenous therapy.
Measured: through study completion, an average of 7 month
Secondary outcomes (23)
Bloodsamples from catheter
Registration of number of blood samples taken from the midline catheter
Measured: through study completion, an average of 7 month
Problems with catheter bloodsampling
Registration of aspiration problems during bloodsampling in midline catheters
Measured: through study completion, an average of 7 month
Bloodsamples (conventional)
Registration of number of blood samples taken from conventional blood samples in both groups
Measured: through study completion, an average of 7 month
Patient satisfaction
Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied
Measured: through study completion, an average of 7 month
Nurse satisfaction
Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied
Measured: through study completion, an average of 7 month
Painscore
Accumulated NRS pain score for all IV catheter insertions. 0 is no pain and 10 is worst imaginable pain
Measured: through study completion, an average of 7 month
Rescue catherizations 1
Rescue PVC's inserted (midline group) (no)
Measured: through study completion, an average of 7 month
Rescue catherizations 2
Rescue central venous catheters including PICC line catheters inserted (no)
Measured: through study completion, an average of 7 month
Time consumption
Total time of cauterization, (measured from the entrance in patient room, to the exit)
Measured: through study completion, an average of 7 month
Catheter dwelltime
Time of catheter duration (hours)
Measured: through study completion, an average of 7 month
Fluid
Accumulated fluids infused (L)
Measured: through study completion, an average of 7 month
Treatment type
Type of medicine infused (all types)
Measured: through study completion, an average of 7 month
Treatment amount
Amount of medicine infused (L)
Measured: through study completion, an average of 7 month
Catheter related infections
Catheters removed due to suspected catheter-related infection (no)
Measured: through study completion, an average of 7 month
Thrombosis 1
Thrombi visible at the catheter tip (no)
Measured: through study completion, an average of 7 month
Thrombosis 2
Deep venous thrombosis of the ipsilateral arm (no)
Measured: through study completion, an average of 7 month
Thrombosis 3
Superficial venous thrombosis of the ipsilateral arm (midline group) (no)
Measured: through study completion, an average of 7 month
Thrombosis 4
Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no)
Measured: through study completion, an average of 7 month
Catheter discontinuation
Reasons for replacing catheters (all types)
Measured: through study completion, an average of 7 month
Insertion complication
Arterial punctures during catheter insertions (no)
Measured: through study completion, an average of 7 month
Insertion complication 2
haematomas during catheter insertions (no)
Measured: through study completion, an average of 7 month
Insertion complication 3
Misplaced catheters (no)
Measured: through study completion, an average of 7 month
Neuropraxia
Post-procedure median nerve palsy/neuropraxia (midline group) (no)
Measured: through study completion, an average of 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start12 Feb 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous CathetersStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 patients in each group, with a total of 2 groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Bundgaard Nielsen, University of Aarhus
- Investigators
- Emma Bundgaard, MS, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457259
- Sponsor's protocol ID
- midlineivauh18
- Status last verified
- Apr 2020
- First submitted
- 13 Feb 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
PubMed 36507736
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03457259
- Acronym / sponsor ID
- midlineivauh18
- Conditions
- Intravenous Catheters
- Keywords
- Midline catheter, peripheral venous catheter, central venous catheter, complication rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 60 patients in each group, with a total of 2 groups
| Arm | Type | Receives |
|---|---|---|
| Midline | Active comparator | Device: MidlinePt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound. |
| Conventional | Active comparator | Device: PVC and/or PICClinePt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission to the Department of Infectious Disease or Department of Heart Disease.
- ≥18 years of age
- Expected requirement for iv. therapy >5 days from the day of enrolment as evaluated by a specialist in infectious diseases.
- Mentally competency
Key exclusion criteria (3 listed)
- Lack of patient consent
- Requirement for a CVC before study eligibility screening or anticipation of an absolute indication for CVC inserted within 24 hours of screening
- Personnel for insertion of midline catheter not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVC and/or PICClineAlso: Conventional catheterizationPt. will receive PVC and/or PICCline | Device | Conventional |
| MidlineAlso: PowerglidePt. will receive midline | Device | Midline |
Primary outcome
Reducing the use of CVC and PVC
Time frame: through study completion, an average of 7 month
The fraction of patients requiring either a CVC - including PICC line - or require ≥ 4PVC insertions during the current admittance to the hospital, including follow-up intravenous therapy.
23 secondary outcomes
Bloodsamples from catheter
Time frame: through study completion, an average of 7 month
Problems with catheter bloodsampling
Time frame: through study completion, an average of 7 month
Bloodsamples (conventional)
Time frame: through study completion, an average of 7 month
Patient satisfaction
Time frame: through study completion, an average of 7 month
Nurse satisfaction
Time frame: through study completion, an average of 7 month
Painscore
Time frame: through study completion, an average of 7 month
Rescue catherizations 1
Time frame: through study completion, an average of 7 month
Rescue catherizations 2
Time frame: through study completion, an average of 7 month
Time consumption
Time frame: through study completion, an average of 7 month
Catheter dwelltime
Time frame: through study completion, an average of 7 month
Fluid
Time frame: through study completion, an average of 7 month
Treatment type
Time frame: through study completion, an average of 7 month
Treatment amount
Time frame: through study completion, an average of 7 month
Catheter related infections
Time frame: through study completion, an average of 7 month
Thrombosis 1
Time frame: through study completion, an average of 7 month
Thrombosis 2
Time frame: through study completion, an average of 7 month
Thrombosis 3
Time frame: through study completion, an average of 7 month
Thrombosis 4
Time frame: through study completion, an average of 7 month
Catheter discontinuation
Time frame: through study completion, an average of 7 month
Insertion complication
Time frame: through study completion, an average of 7 month
Insertion complication 2
Time frame: through study completion, an average of 7 month
Insertion complication 3
Time frame: through study completion, an average of 7 month
Neuropraxia
Time frame: through study completion, an average of 7 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 36507736Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Bundgaard, MS principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVC and/or PICCline and Midline in people with Intravenous Catheters, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing the use of CVC and PVC (time frame: through study completion, an average of 7 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03457259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.